# K051046: Painacea Model XR8 Infrared Heat Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Atlantis Luminescent Products, LLC
- Decided: May 10, 2005 after 15 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875052 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024027: Lightwave Infrared Lamps LW10D and LW30D, Skytech Enterprises, Inc. (2003) Summary page 1.
- K032229: Quantum Warp 10 Light Delivery System, Quantum Devices, Inc. (2003) Summary page 1.

## Recalls of this device
- Oct 25, 2012 · Class II · Z-0517-2013: Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
- Oct 25, 2012 · Class II · Z-0518-2013: Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
- Oct 25, 2012 · Class II · Z-0519-2013: Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.

## Indications for use
The Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Source page: https://510kreport.com/device/K051046
Methodology: https://510kreport.com/methodology